Webinar for Sponsors – COMBINE pilot 'all-in-one' procedure

About the event

COMBINE Project 1 is exploring the coordinated assessment of combined study applications across the clinical trial and medical device regulatory frameworks as well as across multiple Member States. 

The European Commission, participating Member States and the European Medicines Agency (EMA) launched the first phase of the pilot 'all-in-one' coordinated assessment procedure on 13 June 2025. 

The call for sponsors to express their interest will remain open until 31 August 2025. This phase will accept a limited number of combined study applications which involve:

• a clinical trial of a medicinal product
• a simultaneous performance study of an in vitro diagnostic medical device run by the same sponsor.

This webinar is a great opportunity for potential sponsors to learn about this pilot ‘all-in-one’ procedure from the COMBINE Project 1 competent authority leads, to hear about resources available for the pilot and how to respond to the ‘call for expression of interest’. 

• Privacy statement

Background

In the EU, there are legal requirements for the individual authorisation processes of clinical trials of medicinal products, clinical investigations of medical devices and performance studies of in vitro diagnostics (IVDs). 

The requirements are laid out in Regulation (EU) 536/2014 on clinical trials on medicinal products for human use (CTR), Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) respectively.

These Regulations are applied together to develop innovative treatments that combine medicinal products with medical devices or in vitro diagnostics (IVDs). The COMBINE programme addresses the interface between the three Regulations. 

One of the projects in the COMBINE programme involves a pilot to test a new, more efficient way of approving combined studies. The European Commission, EU Member States and the EMA have launched this pilot to allow sponsors to test a medicine and a companion diagnostic at the same time to submit a single application, ensuring more harmonised interactions with the Member States involved. 

Video recording

More information

• Combined studies - European Commission
• COMBINE Project 1 – pilot “all-in-one” coordinated assessment - European Commission
• Health and Food Safety newsletter
• eNews